MalfunctionGBW
ARROW INT'L., INC.
Received Nov 21, 1997 · Event occurred Nov 17, 1997
Report MW1012533 · MDR key 134296
Device
Generic name
Peritoneal Lavage Kit
Manufacturer
Arrow Intl., Inc.Model number
AK-09000(PROD #)Catalog number
DIN #00815357
Lot number
R-158-7B
Product problems
- Material Frayed
- Knotted
- Difficult to Remove
Patient
33 YR
- Surgery, prolonged
Narrative
Description of Event or Problem
WHILE USING KIT GUIDE WIRE FRAYED & KNOTTED INSIDE PT'S ABDOMEN. LARGER INCISION REQUIRED TO REMOVE (SPRING-WIRE GUIDE.)